Here are the latest G-BA decisions from the G-BA meeting held on 3 April 2025 on the early benefit assessments of Keytruda, Padcev, Truqap, Iqirvo, Anzupgo, and Ocaliva.
A complete database of all previous G-BA resolutions is in my membership.
- Keytruda (pembrolizumab); new indication: unresectable or metastatic urothelial carcinoma, first-line, in combination with Padvec – Indication of considerable additional benefit in one subgroup, Indication of not-quantifiable in another subgroup, no additional benefit in third subgroup
- reassessment after expiry of previous resolution: non-small cell lung cancer, PD-L1 expression ≥ 50%, adjuvant therapy after resection and chemotherapy – Hint of considerable additional benefit
- new indication: non-small cell lung cancer, first-line – Indication of minor additional benefit in one of two subgroups
- Padcev (enfortumab vedotin); new indication: unresectable or metastatic urothelial carcinoma, first-line, suitable for platinum-based chemotherapy, in combination with Keytruda – Indication of considerable additional benefit in one subgroup, Indication of not-quantifiable in another subgroup
- Truqap (capivasertib); breast cancer, ER+, HER2-, PIK3CA/AKT1/PTEN alteration(s), after prior therapy, in combination with fulvestrant) – Indication of considerable additional benefit in 1 of 4 subgroups
- Iqirvo (elafibranor); primary biliary cholangitis – Orphan drug, Hint of minor additional benefit
- Anzupgo (delgocitinib); moderate to severe chronic hand eczema – No additional benefit across both subgroups
- Ocaliva (obeticholic acid) – revocation of the decisions from 6 July 2017 and 16 February 2023 due to loss of marketing authorization
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